System To Form, Fill And Seal Flexible Bags - Patent 6957523 by Patents-391

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United States Patent: 6957523


































 
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	United States Patent 
	6,957,523



 Siccardi
 

 
October 25, 2005




 System to form, fill and seal flexible bags



Abstract

A system to form, fill and seal (FFS) flexible bags including the steps of:
     a total printing of the film as it winds off the supply reel; a dry
     cleaning; a gimballed aligning for the folding of the printed and washed
     film; a hot-bar welding of the folded film; a valve welding controlled by
     an algorithm; a humidification treatment of the valve cavity; a shaping of
     the bags by hot tools also controlled by an algorithm; and a high
     precision dosage of the filling liquid.


 
Inventors: 
 Siccardi; Alberto (Villa Luganese Canton Ticino, CH) 
 Assignee:


Baxter International Inc.
 (Deerfield, 
IL)





Appl. No.:
                    
 10/087,563
  
Filed:
                      
  February 28, 2002

 Related U.S. Patent Documents   
 

Application NumberFiling DatePatent NumberIssue Date
 316165May., 1999
 PCTIB9701458Nov., 1997
 

 
Foreign Application Priority Data   
 

Nov 22, 1996
[IT]
MI96A2451



 



  
Current U.S. Class:
  53/425  ; 422/82.01; 53/133.1; 53/133.2; 53/167; 53/410; 53/451; 53/551; 53/76
  
Current International Class: 
  B65B 61/18&nbsp(20060101); B65B 55/02&nbsp(20060101); B65B 55/04&nbsp(20060101); B65B 55/10&nbsp(20060101); B65B 061/00&nbsp()
  
Field of Search: 
  
  

















 53/425,426,551,550,410,411,167,33.1,33.2,451,75,76 493/5,17,210,921 422/82.01,82.02
  

References Cited  [Referenced By]
U.S. Patent Documents
 
 
 
1951035
March 1934
Parker

2289610
July 1942
Wallace

3451403
June 1969
Madsen

3683757
August 1972
Lenk

4326574
April 1982
Pallaroni et al.

4396582
August 1983
Kodera

4467003
August 1984
Pallaroni et al.

4587793
May 1986
Brennan et al.

4656813
April 1987
Baldini et al.

4731980
March 1988
Worden et al.

4732299
March 1988
Hoyt

4887913
December 1989
Sengewald

5069017
December 1991
Fabricius

5129212
July 1992
Duffey et al.

5174096
December 1992
Fukuda

5473857
December 1995
Keeler

5606844
March 1997
Takagaki et al.

5653428
August 1997
Dufour et al.

5934043
August 1999
Aindow et al.

5976299
November 1999
Ivey



 Foreign Patent Documents
 
 
 
197 52 648
Mar., 1999
DE

0 067 420
Dec., 1982
EP

0 142 758
May., 1985
EP

0 618 136
Oct., 1994
EP

0 658 421
Jun., 1995
EP

2 444 619
Jul., 1980
FR

830 859
Mar., 1960
GB

2142282
Jan., 1985
GB

WO 95/16565
Jun., 1995
WO



   Primary Examiner:  Sipos; John


  Assistant Examiner:  Harmon; Christopher


  Attorney, Agent or Firm: Kelly; Paula J. F.
Reagen; Joseph F.
    Bell, Boyd & Lloyd LLC



Parent Case Text



RELATED APPLICATIONS


This Application is a continuation of application Ser. No. 09/316,165 filed
     May 21, 1999 which is a continuation of International Application No.
     PCT/IB97/01458, filed Nov. 18, 1997. U.S. Ser. No. 09/316,165 and
     International Application No. PCT/IB97/01458 are herely incorporated
     herein by reference, and made a part hereof.

Claims  

What is claimed is:

1.  A method of forming flexible plastic containers and filling with infusion-type solutions, the method comprising the steps of: printing of a film wound off a supply reel; 
directing a gas from a gas applicator toward and across a dry surface of the film to remove impurities therefrom;  carrying the impurities away from the dry film surface with a nozzle juxtaposed the gas applicator to dry clean the film without contact
with a liquid or system supports;  aligning the film for folding thereof;  hot-bar longitudinal welding of the folded film to create a bag;  sterilizing a cavity of a valve by humidifying the cavity without exposing the cavity to ultraviolet radiation; 
welding the valve to the film using a control algorithm to control the speed and position of a welding head during the welding head's approach to an anvil;  shaping the bag using hot tools controlled by an algorithm;  and supplying a high precision
dosage of a filling liquid into the bag.


2.  The method of claim 1, wherein the hot-bar longitudinal welding of the film creates a vertical seal.


3.  The method of claim 1, wherein the cavities of the valve are subjected to humidification outside the bag and without contact with the filling solution by a means to dose the liquid as a function of a volume of the cavity.


4.  The method of claim 3, wherein the humidification step is effected by a humidification apparatus located downstream from a vibrator associated with the step of feeding the valves for welding onto the bag, and wherein a humidification control
that controls the humidification of the cavities of the valves is located downstream from the humidification apparatus.


5.  The method of claim 3, wherein a liquid used for humidification is selected from the group consisting of distilled water, physiological solutions and hydrogen peroxide.


6.  The method of claim 4, wherein the humidification apparatus includes a source of sterile liquid, a dosing valve, a fluxstate, and a nozzle that is moved by a piston controlled by a sensor, the nozzle including a lance for penetration into the
valve cavities, the discharged sterile liquid being detected by a circuit with electric bridging.


7.  The method of claim 5, wherein hydrogen peroxide is used to sanitize and detect electric conductability in the cavities.


8.  The method of claim 1, wherein the printing of the film wound off the supply reel is facilitated by a hot printer having a hot press, a pigmented film, and a film impression member that impresses the film wound off the supply reel.


9.  The method of claim 1, wherein the film is dry cleaned with purified air.


10.  The method of claim 1, further including the step of welding a suspension ring to the bag.


11.  The method of claim 1, further including the step of forming a suspension hole in the bag.


12.  The method claim 1, further including the step of accumulating the film prior to aligning the film.


13.  The method of claim 1, wherein the filling liquid is precisely dosed in a station that includes an inlet portion having a contribution regulation valve, a constant pressured valve, and a lobed flowmeter having a Hall effect that controls the
dosing of the filling liquid.


14.  The method of claim 1, further including the step of washing a portion of the film with the filling liquid prior to the bag being welded longitudinally.


15.  The method of claim 1, further including the step of transverse welding the film to form the bag.


16.  The method of claim 15, wherein the transverse welding is carried out with mobile bars heated by electric resistances of high output having a plurality of temperature control points and cooling effected by mobile cold bars that cool the
welding.


17.  The method of claim 16, wherein the cold bars contain means for cutting and separating the bags.


18.  The system of claim 16, wherein the valve welding is accomplished with a position transducer, a cylinder, a slide, a sonotrode and a piezoelectric transducer.


19.  A method of forming flexible plastic containers and filling with infusion-type solutions, the method comprising the steps of: printing of a film wound off a supplying reel;  directing a gas from a gas applicator toward and across a dry
surface of the film to remove impurities therefrom;  carrying the impurities away from the dry film surface and the gas out through a nozzle juxtaposed the gas applicator to dry clean the film without contact with a liquid or system supports; 
accumulating the film;  aligning the film for folding thereof;  washing the film with the filling liquid;  hot-bar longitudinal welding and transverse welding of the folded film to create a bag;  sterilizing a cavity of a valve by humidifying the cavity
without exposing the cavity to ultraviolet radiation;  welding the valve to the film using a control algorithm to control the speed and position of a welding head during the welding head's approach to an anvil;  shaping the bag using hot tools controlled
by an algorithm;  forming a suspension hole in the bag;  and supplying a high precision dosage of a filling liquid into the bag.


20.  The method of claim 13, wherein the dry cleaning step occurs prior to sterilization.


21.  The method of claim 1, wherein the dry cleaning step further comprises suspending the printed film between gas application chambers.


22.  The method of claim 1, wherein the dry cleaning step further comprises applying the gas to the printed film through a first nozzle and removing the gas from the printed film through nozzles prior to and after the first nozzle in a film
travel direction.


23.  The method of claim 1, wherein the step of sterilizing a cavity of a valve by humidifying the cavity further comprises controlling humidification in the valve cavity by measuring electrical conductivity in the valve cavity.
 Description  

TECHNICAL FIELD


The present invention concerns a system to form, fill and seal (F.F.S.) containers of flexible plastic materials, in particular sterilizable bags containing solutions for the administration of infusion solutions.


BACKGROUND OF THE INVENTION


Numerous prior art systems for manufacturing flexible containers, or bags, for use with infusion solutions in the medical field are known.  For example, U.S.  Pat.  No. 4,656,813, describes a system for industrial production of these types of
bags.  These bags are sometimes generally referred to as form, fill and seal (F.F.S.) containers.  These bags typically have a laminated construction and include a valve to accommodate various connectors of an infusion apparatus, such as a luer-type
valve.  The bags are typically sterilized during or after the manufacturing process.  Sterilization of a bag that incorporates various design features, such as valves, can be difficult.  The manufacturing and sterilizing process becomes even more
difficult with present day bags that may be required to have additional features, such as means for bag suspension, complex valves, or twin-valve systems.  These features create areas of the bag that are difficult to access by a sterilization solution
during the sterilization process.  This can cause variation in the sterilization times of these areas, which in turn can cause incomplete or ineffective sterilization.  This variation can also have an effect on the proper selection of sterilization
solution dosages.


Therefore, it is an object of the present invention to provide a system and associated method for manufacturing F.F.S.  containers of flexible plastic materials that can be easily sterilized without the disadvantages of previous systems and
methods.


It is also an object of the present invention to provide a system and method for manufacturing F.F.S.  containers of flexible plastic materials that are characterized by high manufacturing efficiency, sterilization reliability, and precision.


It is a further object of the present invention to provide a less expensive and space-efficient system for manufacturing F.F.S.  containers of flexible plastic materials.


These and other objects will become readily apparent after review of the specification, drawings, and accompanying claims.


SUMMARY OF THE INVENTION


The system of the present invention includes a method of manufacturing form, fill and seal (F.F.S.) containers, or bags, made from flexible plastic materials.  The system and associated method generally include the steps of: (1) feeding from at
least one reel a plastic and flexible material in the form of a film or pellicle, preferably multilayer, for forming the bag; (2) printing the material pulled from the reel; (3) winding the printed material; (4) washing the printed material; (5) aligning
and folding the printed and washed film; (6) welding the folded film in a first direction; (7) feeding and applying valves on the surface of the folded and welded film; (8) making a second welding in a second direction; and, (9) cooling and cutting the
bags to send to them for overwrapping and sterilizing. 

BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 is a block diagram of the system of the present invention.


FIG. 2 is a schematic diagram of an embodiment of the system of FIG. 1.


FIG. 2A is a partial view of a variation of the embodiment disclosed in FIG. 2.


FIG. 2B is a partial perspective view of an embodiment of a dry cleaning means of the present invention.


FIG. 2C is a partial perspective view of the embodiment of the dry cleaning means of FIG. 2B.


FIG. 3 is a perspective view of a schematic representation of a preferred embodiment of the system of FIG. 1.


FIG. 4 is an elevational view, partially in section, of a first embodiment of a two-valve structure of a bag manufactured according to the method of the present invention.


FIG. 5 is an elevational view, partially in section, of a second embodiment of a two-valve structure of a bag manufactured according to the method of the present invention.


FIG. 6 is a top plan view of a bag manufactured according to the method of the present invention and incorporating the valve assembly of FIG. 4.


FIG. 7 is a top plan view of a bag manufactured according to the method of the present invention and incorporating the valve assembly of FIG. 5.


FIG. 8 is a schematic view in partial cross-section of a humidification means for humidifying the valves of the bags manufactured according to the method of the present invention.


FIG. 9 is a schematic view of a high precision liquid dosing means for filling the bags manufactured according to the method of the present invention.


FIG. 10 is a schematic view of a filling portion of an actuating machine of the system of the present invention that incorporates the dosing means of FIG. 9.


FIG. 11 is an elevational side view of an embodiment of a total print station of the system of the present invention.


FIG. 12 is a perspective view of a valve welding station of the system of the present invention.


FIG. 13 is a perspective view of a final welding and molding block of the system of the present invention. 

DETAIL DESCRIPTION OF THE PREFERRED EMBODIMENTS


The system of the present invention is represented in FIGS. 1 and 2.  The system comprises at least five stations, each involving one or more steps of the method of the present invention.


Referring to FIG. 1, block 1 represents the supplying station that feeds a film F from a first reel B. The dashed line rectangles B' and B" represent optional reel configurations.  The reel B' can be placed in addition to and parallel to the
first reel B. The reel B' is preferably of the same width as the first reel B. Alternatively, the reel B" can be used in lieu of reels B or B'. In this case, the reel B" is preferably n times the width of B or B'. Referring to FIG. 2, a tension
adjustment and braking mechanism DF is provided in communication with the reels B and/or B', or B".


Block 2 of FIG. 1 represents a total printing (TP) station 2a that is followed by an accumulation station 2b.  The TP station 2a provides in-line printing of the film.  The accumulation station 2b accumulates the printed film in-line with the TP
station 2a.  The TP station 2a includes a hot printer that utilizes a hot press and a pigmented film to imprint characters on the film.  The characters of the printed matter are on a cliche of the hot printer.  The TP station 2a is preset to obtain the
character printing information, such as a prescription, a lot number, or data relating to the production.  Furthermore, a print menu incorporated into the TP station 2a allows for the setup of various printing parameters, such as bag size (50 cc to 5,000
cc), temperature, speed, and the like.


Block 3 of FIG. 1 represents a washing station phase that comprises a single dry washing stage.  The film entering the dry washing stage is labeled FST and the film exiting the dry washing stage is labeled FSTL, as shown in FIG. 1.  The dry
washing stage does not allow the film to contact any liquids or supports of the system.  A preferred embodiment of the washing stage is represented in FIGS. 2B and 2C.  In this embodiment, the washing stage is formed by two superimposed chambers 101 and
102 forming a central slot for the printed film FST to pass therethrough.  The printed film FST is suspended and subjected to filtered air AF flowing from nozzles 104 and 107.  The air flows over the printed film FST and carries away any particles or
impurities from the printed film FST.  The air flows out through nozzles 103, 105, 106, and 108.  The stations represented by blocks 2 and 3 can operate and handle a plurality of film configurations, such as in the case of using two reels B and B' of
equal length, or using a single reel B" having a width n times greater than B or B'.


Block 4 of FIG. 1 represents a station comprising four substeps for handling the printed and dry washed film FSTL.  The four substeps comprise accumulation 4b, gimballing alignment 4d, folding 4e, and towing 4f.  Compared to prior art systems, a
drying phase is not needed because dry washing is utilized.  Furthermore, a sterilization step that utilizes ultraviolet radiation has also been eliminated.


Referring to FIG. 2, the printed and dry washed film FSTL is first aligned by alignment rollers 4b.  First and second folding rollers 4e and 4e' facilitate a folding prism PR therebetween for folding the printed and dry washed film FSTL.  A
towing roller 4f cooperates with the second folding roller 4e' to complete the handling station.


Block 5 of FIG. 1 represents the bag formation step of the manufacturing process.  The bag formation step involves vertical welding of the film as well as the attachment of one or more valves.  The bag formation step comprises a vertical welding
substation 5a and a valve attachment substation 5b.  The bag is formed and the valves are attached by welding.  FIGS. 4 and 5 show two valve structures that can be attached to the bag.  Such valves are disclosed in U.S.  Pat.  No. 4,467,003.


In more detail, the bag formation step of block 5 comprises a vibrator 5b1 for feeding the valves during the assembly process, a humidification means, such as a spray wetter 5b2, for wetting the valve cavities, a detection and controlling means
5b3 for the spray wetter, a suspension hole forming means 5c that forms a suspension hole in the bag, and a suspension ring application means 5f that applies suspension rings to the suspension hole of the bag.  A vibrator 5f1 is also included for feeding
the suspension rings during the assembly process.


In a preferred embodiment of the invention, the valve welder is an ultrasound welder with open ring control of position and approach speed.  FIG. 12 shows the valve attachment station 5b as a welding and molding station.  The valve attachment
station 5b comprises a position transducer 81, a cylinder 82, a slide 83, a sonotrode 84 (welding head) and a transducer 85.  The system allows for continuous checking of the position and speed of the sonotrode 84 at substation 5b with respect to an
anvil l (not shown).  With a PID (Proportional Integral Derivative) algorithm sampled to a thousandth of a second, the speed and acceleration/deceleration of the sonotrode/anvil impact was optimized.  This allows the welding operation and the resulting
weld to be optimized with respect to the bag material utilized.


Referring to FIG. 1, station SP fills the bag with the proper dose, or volume, of the liquid RIEM.  The station SP is a precise, substantially automatic station that includes electropneumatic valves 60 and 62 that are fed by line 61.  A
processing switchboard 63 allows for control of the valves 60 and 62.  The valves 60 and 62 provide a double electropnuematic thrust and permit opening and closing of the valves 60 and 62 in a time of 3 to 5 thousandths of a second, which provides a
dosage tolerance of +/-1 cc per dosage quantity.


In a preferred embodiment, the valves 60 and 62 are controlled by pulses generated by a lobed flowmeter that utilizes a Hall effect.  FIGS. 9 and 10 depict the station SP in more detail.


FIG. 13 depicts a mechanism for shaping the bags contemporaneously with horizontal welding via movable bars 71 and 73.  The bars 71 and 73 are heated by electric heating elements and allows the bars 71 and 73 to compress and thermoform the bags
without the formation of ears.  The mechanism of FIG. 13 also includes a non-heated cutting edge 72 and a cutting edge support 74.


A PID type algorithm is used to control the temperature of the bars 71 and 73.  For example, the temperature can be controlled on twelve selected points on the bars 71 and 73.  The non-heated bars 72 and 74 provide immediate cooling of the
thermoformed area of the bag.  The bars 72 and 74 also cut the bags to the desired dimension.


The valve cavities depicted in FIGS. 4 and 5 can be humidified, or wetted, by use of the mechanism depicted in FIG. 8.  The mechanism includes a valve VS, a fluxstate FLU, a nebulization nozzle US, a piston PM to move the nozzle US, a sensor SEP
that controls the piston PM, a bridging circuit for the measurement of the electrical conductivity in the wetted cavity that provides humidification control, and a discharge channel for the wetting liquid CSLB.  The nozzle US includes a lance for
penetration into the valve cavities.  The wetting liquid CSLB is preferably distilled water, a physiological solution, or hydrogen peroxide.  The wetting liquid is used to sanitize and detect electric conductability in the cavities.


The system of the present invention can be used to weld one or more valves onto the same bag or even welding valves only on a particular series of bags, e.g., even or odd numbered bags.  The film F in FIG. 1 used to form the bags can be
multilayer, comprising polymers or copolymers that include laminated olefins, amides, esters, or the like, as disclosed in U.S.  Pat.  No. 4,326,574.  Preferably, the film F is coextruded, such as disclosed in Applicant's European Patent Application
Number 0658421 and International Patent Number WO 95/16565.


Optimal results have been obtained with coextruded film based on two external layers of ethylene and propylene copolymers or of two chemically diverse layers, such as polyethylene/polypropylene.  The adhesion of the two layers is ensured by an
appropriate coextruded binding, which is also a polyolefin.  By choosing the appropriate composition of the external layers, the binding and the adhesion of the layers can be optimized with respect to weld temperatures and weld resistance during
manufacturing.  Various properties of the bag material may also be optimized, such as strength of the bag and bag weld, transparency, sterilizability, etc. The coextruded films can also have additional layers that are themselves coextruded or laminated
to the coextruded films.


While the specific embodiments have been illustrated and described, numerous modifications come to mind without significantly departing from the spirit of the invention and the scope of protection is only limited by the scope of the accompanying
claims.


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